Digital Biopsy - Market Insights, Competitive Landscape, and Market Forecast - 2032

Digital Biopsy Market by Technique (Radiofrequency Imaging, Ultrasound, Optical Imaging, X-ray, and Others), Indication (Skin Cancer, Brain Cancer, Breast Cancer, and Others), End-User (Hospitals, Diagnostic Imaging Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing incidence of cancer globally and rising shift towards non-invasive diagnostic procedures.

The digital biopsy market is estimated to grow at a CAGR of 16.87% during the forecast period from 2025 to 2032. The demand for digital biopsy is rising globally, driven by the increasing incidence of cancers such as breast cancer, brain cancer, melanoma, squamous cell carcinoma, basal cell carcinoma, and others. A growing preference for non-invasive diagnostic methods, along with ongoing technological advancements in digital biopsy systems, is further supporting this trend. These factors are creating a strong foundation for sustained market growth, positioning the digital biopsy market for steady and robust expansion from 2025 to 2032.

Digital Biopsy Market Dynamics:

According to data from GLOBOCAN (2023), approximately 20 million new cancer cases were reported globally in 2022, with projections indicating a rise to 32.6 million cases by 2045. This steep increase underscores the urgent need for more efficient, accurate, and scalable diagnostic technologies such as digital biopsy solutions.

Skin cancer is among the fastest-growing cancer types globally. As reported by the International Agency for Research on Cancer (IARC, 2022), an estimated 330,000 new melanoma cases were diagnosed worldwide in 2022, with nearly 60,000 deaths. Similarly, the National Institutes of Health (2025) reported that approximately 331,722 individuals were diagnosed with melanoma globally in 2024. The rising incidence of skin cancer is significantly contributing to the demand for digital biopsy technologies, which offer a non-invasive, repeatable, and real-time method for screening and early detection, especially critical for melanoma and other skin cancers.

Breast cancer also remains a major global health challenge. According to the World Health Organization (2024), 2.3 million women were diagnosed with breast cancer in 2022, with 670,000 deaths recorded globally. Digital biopsy solutions help address this challenge by enabling clinicians to non-invasively differentiate between benign and malignant lesions, reduce unnecessary surgical biopsies, and accelerate diagnostic decision-making, ultimately leading to improved patient outcomes.

Furthermore, the growing incidence of brain tumors further highlights the need for advanced diagnostic methods. Data from Brain Tumour Research UK (2024) revealed that over 16,000 people were diagnosed with brain tumors annually in the UK, while the Australian Government (2024) reported about 2,000 new brain cancer cases each year. Digital biopsy technologies provide a transformative approach in such cases by helping to identify tumor type and grade (e.g., glioblastoma versus low-grade gliomas) without the need for physically removing tissue, minimizing patient risk, and supporting more timely interventions.

In addition to rising disease burden, technological innovation and product approvals are also accelerating market growth. For instance, in November 2023, BrainSpec announced that the FDA approved BrainSpec Core™, a cutting-edge non-invasive digital biopsy device designed for the detection of brain tumors. Utilizing advanced imaging technology, BrainSpec Core™ analyzes the concentration of chemicals within the brain to generate a virtual biopsy, all through the use of standard MRI scanners. This innovative approach allows for accurate tumor diagnosis without the need for invasive tissue removal, marking a significant advancement in brain cancer diagnostics.

However, the technical limitations associated with digital biopsy devices and the availability of alternative products, among others, are some of the key constraints that may limit the growth of the digital biopsy market.

Digital Biopsy Market Segment Analysis:

Digital Biopsy Market by Technique (Radiofrequency Imaging, Ultrasound, Optical Imaging, X-ray, and Others), Indication (Skin Cancer, Brain Cancer, Breast Cancer, and Others), End-User (Hospitals, Diagnostic Imaging Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the technique segment of the digital biopsy market, the radiofrequency imaging category is estimated to account for the largest market share in 2024. The growth of this category is primarily driven by the rising global incidence of cancer and the increasing adoption of advanced, non-invasive diagnostic technologies such as radiofrequency imaging and digital biopsy devices.

According to the European Commission (2023), in 2022, approximately 2.74 million new cancer cases were reported in Europe, with around 3.7 million new cases diagnosed annually across the continent. Similarly, the World Health Organization (2023) reported that over 2.3 million people were diagnosed with cancer each year in the South-East Asia Region. This growing cancer burden has significantly increased demand for early detection and minimally invasive diagnostic solutions, fueling the demand for radiofrequency imaging digital biopsy solutions.

One of the most notable benefits of radiofrequency imaging digital biopsy devices is their non-invasive or minimally invasive nature, which significantly enhances their appeal in modern clinical settings. These advanced tools leverage imaging technologies and artificial intelligence (AI) to analyze tissues in real time, thereby reducing or eliminating the need for traditional surgical biopsies.

As a result, they enable faster diagnosis, allow for repeatable assessments for ongoing monitoring, and improve patient comfort by minimizing physical trauma. Additionally, by avoiding tissue excision, these devices help lower the risk of complications such as bleeding, infection, and scarring, making them particularly valuable in primary care and outpatient environments.

Moreover, the market is witnessing technological innovation and regulatory momentum. In January 2024, DermaSensor, Inc. received FDA clearance for DermaSensor, a digital biopsy device designed to detect all three common types of skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma. This marked a significant milestone in expanding access to non-invasive cancer diagnostics at the primary care level.

Thus, the factors mentioned above are likely to boost the market segment and thereby increase the overall market of digital biopsy across the globe.

North America is expected to dominate the overall digital biopsy market:

North America is projected to hold the largest share of the digital biopsy market in 2024, driven by several key factors. This regional dominance is primarily attributed to the rising incidence of cancer, growing adoption of non-invasive diagnostic methods, and a strong focus on technological innovation. The region benefits from a well-established healthcare infrastructure, favorable reimbursement policies, and high awareness among clinicians. Additionally, various product approvals and advancements by key market players are accelerating adoption and solidifying North America's dominant market position.

According to data from the International Agency for Research on Cancer (2025), the number of new cancer cases in the U.S. was 2,380,189 in 2022, with projections indicating a significant rise to 3,380,124 cases by 2045. Among these, leukemia had 63,100 new cases in 2022, expected to increase to 88,600 by 2045. Similarly, data from the Canadian Cancer Society (2024), over 11,300 people were diagnosed with melanoma skin cancer in Canada.

According to the American Cancer Society (2025), an estimated 104,960 new cases of melanoma were expected to be diagnosed in the U.S. in 2025, along with approximately 5.4 million cases of basal and squamous cell skin cancers annually. The same source also reported that 24,820 malignant tumors of the brain or spinal cord (14,040 in males and 10,780 in females) were projected to be diagnosed in 2025.

Additionally, in 2024, approximately 310,720 new cases of invasive breast cancer were reported. This increasing cancer burden is significantly driving demand for advanced digital biopsy solutions for early screening and accurate diagnosis.

Moreover, the market is being fueled by technological advancements and product approvals. For example, in October 2024, VPIX Medical Inc. announced that it had received FDA approval for its digital biopsy system, cCeLL-In vivo. This device works by converting laser scanning signals into digital tissue images through direct contact with the patient's body, enabling accurate, real-time diagnosis of brain cancer.

Collectively, the rising burden of cancer, the shift towards non-invasive diagnostics, and product approvals by key players are propelling the demand for digital biopsy in North America, reinforcing its position as a leading region in the global market.

Digital Biopsy Market Key Players:

Some of the key market players operating in the digital biopsy market include DermaSensor, Inc., SciBase, VITA IMAGING, Inc., MetaOptima Technology Inc., VPIX Medical Inc., Mauna Kea Technologies, Skin Analytics, Trafita Medical System, BRAINSPEC, Imaging Biometrics, LLC, Optovibronex, LLC, FUJIFILM Holdings Corporation, Canon Inc., VivaScope GmbH, and others.

Recent Developmental Activities in the Digital Biopsy Market:

• In May 2025, SciBase Holding AB announced that over 300,000 Nevisense melanoma detection tests had been used worldwide. Nevisense is a digital biopsy device that helps dermatologists assess suspicious moles and evaluate a patient's melanoma risk, enabling more accurate and personalized care at the point of diagnosis.  

Key takeaways from the digital biopsy market report study

• Market size analysis for current digital biopsy market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the digital biopsy market.
• Various opportunities available for the other competitors in the digital biopsy market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current digital biopsy market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for digital biopsy market growth in the future?

Target audience who can benefit from this digital biopsy market report study

• Digital biopsy product providers
• Research organizations and consulting companies
• Digital biopsy-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in digital biopsy
• Various end-users who want to know more about the digital biopsy market and the latest technological developments in the digital biopsy market.

Frequently Asked Questions for the Digital Biopsy Market:

1. What is digital biopsy?

• Digital biopsy is a non-invasive diagnostic technique that uses advanced imaging technologies, artificial intelligence (AI), and data analysis to examine tissues or organs at the cellular or subcellular level without the need for physically extracting a tissue sample, as in a traditional biopsy.

2. What is the market for digital biopsy?

• The digital biopsy market is estimated to grow at a CAGR of 16.87% during the forecast period from 2025 to 2032.

3. What are the drivers for the digital biopsy market?

• The demand for digital biopsy is rising globally, driven by the increasing incidence of cancers such as breast cancer, brain cancer, melanoma, squamous cell carcinoma, basal cell carcinoma, and others. A growing preference for non-invasive diagnostic methods, along with ongoing technological advancements in digital biopsy systems, is further supporting this trend. These factors are creating a strong foundation for sustained market growth, positioning the digital biopsy market for steady and robust expansion from 2025 to 2032.

4. Who are the key players operating in the digital biopsy market?

• Some of the key market players operating in the digital biopsy market include DermaSensor, Inc., SciBase, VITA IMAGING, Inc., MetaOptima Technology Inc., VPIX Medical Inc., Mauna Kea Technologies, Skin Analytics, Trafita Medical System, BRAINSPEC, Imaging Biometrics, LLC, Optovibronex, LLC, FUJIFILM Holdings Corporation, Canon Inc., VivaScope GmbH, and others.

5. Which region has the highest share in the digital biopsy market?

• North America is projected to hold the largest share of the digital biopsy market in 2024, driven by several key factors. This regional dominance is primarily attributed to the rising incidence of cancer, growing adoption of non-invasive diagnostic methods, and a strong focus on technological innovation. The region benefits from a well-established healthcare infrastructure, favorable reimbursement policies, and high awareness among clinicians. Additionally, various product approvals and advancements by key market players are accelerating adoption and solidifying North America's dominant market position.

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